TEMP Senior Quality Engineer I (Supplier Development)

Job Description

Position Overview :

Quality Engineer has the primary responsibility of supporting the supplier development and manufacturing of components and parts for Class I, II and III medical devices. Commodities will include electronics, molding, electro-mechanical, as well as mechanical industries. This position supports the review of new / existing designs for component DfX impact at the upstream supply chain, onboards new suppliers to the ASL and establish sourcing links upon completion of parts qualification. This position also supports the Quality Engineering staff with the technical liaison activities between R&D, Supplier Quality, commercial operations staff and the supplier. This person will also support the supplier part qualification program. Responsibilities include review of and filing of PPAP documentation, transact sourcing link of parts to supplier based on completion and approved parts qualification. Additional work around initiating FAI forms for inspection and coordinating inspection work with QA operations. Support creation of inspection plans at supplier. The Quality Engineer will ensure all procedures and records meet regulatory and requirements.

Responsibilities :

• Support Quality Engineering, R&D and commercial engineering in the evaluation of new suppliers and components.
• Support the engineering teams to assess technical and manufacturing capabilities of prospective suppliers and define necessary technical requirements, tests and documentation for sourced products.
• Provide the product development teams with SME knowledge of manufacturing processes, such as PCBA manufacturing, OEM electro-mechanical assembly, machining / metal forming and plastics molding.
• Support supplier validations.
• Support execution of supplier qualifications including evaluation of supplier product realization processes to ensure suppliers can produce components that consistently meet pre-determined specifications.
• Support MSA at supplier and work with Quality Engineers and Design / Manufacturing Engineering to ensure continuity of Product and Process Quality Control Plans with Receiving Inspection.
• Investigate and disposition identified supplier related nonconforming components.
• Support Supplier Change Notification program.

o Evaluate supplier changes request and coordinate review with internal staff. o Collaborate with suppliers on internal specification changes. Supplier Quality

Experience :